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Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post-hoc analyses of a randomized, double-blind, phase III study.

ABSTRACT: AIMS/INTRODUCTION:To investigate the efficacy/safety of dulaglutide once-weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes. MATERIALS AND METHODS:This was a post-hoc analysis of a Chinese randomized, double-blind, non-inferiority, phase III study. Patients (n = 572) with inadequate glycemic control received dulaglutide 1.5 mg (n = 189) or 0.75 mg (n = 194) once-weekly or glimepiride (1-3 mg/day; n = 189) for 26 weeks. The primary objective of the study was to investigate the non-inferiority of dulaglutide 1.5 mg versus glimepiride by the change from baseline to week 26 in glycated hemoglobin (non-inferiority margin 0.4%). RESULTS:Dulaglutide 1.5 mg and 0.75 mg were non-inferior (P < 0.001) and superior (P ? 0.002) versus glimepiride for the change in glycated hemoglobin from baseline to week 26. The least-squares mean differences (95% confidence interval) versus glimepiride were dulaglutide 1.5 mg, -0.53% (-0.74, -0.32) and dulaglutide 0.75 mg, -0.32% (-0.53, -0.12). Significantly more patients attained glycated hemoglobin <7.0% at week 26 in the dulaglutide 1.5 mg (71.7%) versus the glimepiride (57.5%; P = 0.005) group. The decrease from baseline to week 26 in fasting blood glucose was significantly more pronounced in both the dulaglutide groups versus the glimepiride group (P < 0.01). The overall incidence and rate of hypoglycemia were lower in both of the dulaglutide groups versus the glimepiride group. At week 26, bodyweight had increased from baseline in the glimepiride group and decreased from baseline in both dulaglutide groups. The most frequent gastrointestinal drug-related adverse events with dulaglutide were diarrhea, abdominal distension, nausea and vomiting. CONCLUSIONS:These findings support once-weekly dulaglutide monotherapy as a treatment for Chinese patients with early stage type 2 diabetes.

SUBMITTER: Shi LX

PROVIDER: S-EPMC6944837 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post-hoc analyses of a randomized, double-blind, phase III study.

Shi Li Xin LX Liu Xiao Min XM Shi Yong Quan YQ Li Quan Min QM Ma Jian Hua JH Li Yan Bing YB Du Li Ying LY Wang Feng F Chen Lu Lu LL

Journal of diabetes investigation 20190613 1

<h4>Aims/introduction</h4>To investigate the efficacy/safety of dulaglutide once-weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes.<h4>Materials and methods</h4>This was a post-hoc analysis of a Chinese randomized, double-blind, non-inferiority, phase III study. Patients (n = 572) with inadequate glycemic control received dulaglutide 1.5 mg (n = 189) or 0.75 mg (n = 194) once-weekly or glimepiride (1-3 mg/day; n = 189) for 26 weeks. The primary objective of the study ...[more]

PMID: 31102326

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Project description:IntroductionGlucagon-like peptide (GLP)-1 receptor agonists are glucose-lowering agents associated with weight loss, cardiovascular benefits, and low hypoglycemic risk and are recommended by recent guidelines as first-line therapy for some patients with type 2 diabetes (T2D). This post hoc analysis of the AWARD-CHN1 study compared the efficacy and safety of once-weekly dulaglutide with glimepiride in oral antihyperglycemic medication (OAM)-naïve Chinese patients with T2D.MethodsAWARD-CHN1 was a phase 3, double-blind study with 737 patients randomized 1:1:1 to once-weekly dulaglutide (1.5 or 0.75 mg) or glimepiride (1-3 mg/day). This is a post hoc analysis of AWARD-CHN1 based on mixed-model repeated measures using a modified intent-to-treat analysis set with only the OAM-naïve Chinese population.ResultsThere were 264 OAM-naïve Chinese patients included in this analysis (dulaglutide 1.5 mg, n = 87; dulaglutide 0.75 mg, n = 90; glimepiride, n = 87). A greater glycated hemoglobin (HbA1c) reduction from baseline was observed with dulaglutide 1.5 mg and 0.75 mg compared to glimepiride (- 2.02% and - 1.84% vs - 1.37%, respectively; both P < 0.001). Significantly more patients in dulaglutide 1.5 mg and 0.75 mg groups achieved HbA1c targets < 7.0% compared to glimepiride (86.2% and 81.1% vs 65.5%; P = 0.002 and P = 0.026, respectively). Beta cell function was significantly increased for dulaglutide groups compared to glimepiride. Mean body weight was significantly reduced for dulaglutide 1.5 mg and 0.75 mg compared to glimepiride (- 1.40 kg and - 0.96 kg vs + 0.73 kg, respectively; both P < 0.001). Through 26 weeks, 7.9%, 4.2%, and 18.2% of patients reported hypoglycemia, and 40.4%, 23.2%, and 8.0% of patients reported at least one gastrointestinal treatment emergent adverse event, in dulaglutide 1.5 mg, 0.75 mg, and glimepiride groups, respectively.ConclusionsIn this post hoc analysis, dulaglutide was effective in reducing both HbA1c and weight with favorable tolerability and safety profile, which is consistent with results seen in larger international dulaglutide monotherapy studies.Trial registrationClinicalTrials.gov NCT01644500.

Project description:ObjectiveIn SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.DesignAnalyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5-10, >10 years), HbA1c (≤7.5, >7.5-8.5, >8.5% (≤58, >58-69, >69 mmol/mol)) and body mass index (BMI) (<30, 30-<35, ≥35 kg/m2).Setting194 sites; 16 countries.ParticipantsSubjects with T2D (n=1199) exposed to treatment.InterventionsSemaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measuresChange in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.ResultsHbA1c and BW reductions (estimated treatment difference ranges: -0.22 to -0.70%-point; -1.76 to -3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.ConclusionsConsistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration numberNCT02648204.

Project description:To evaluate suicidal thoughts in relationship to depressive symptom severity and reasons for living in patients hospitalized for major depressive disorder (MDD).A post hoc analysis was conducted of a randomized, double-blind, parallel-group trial involving hospitalized patients with MDD (DSM-IV criteria) who received duloxetine 60 mg once daily or duloxetine 60 mg twice daily for 8 weeks. After 4 weeks, the dose for nonresponders receiving 60 mg once daily could be increased to 60 mg twice daily (double-blind). The study was conducted between February 9, 2007, and August 26, 2008 at 43 centers in 4 countries across Europe and South Africa. Suicidal thoughts were assessed with Montgomery-Asberg Depression Rating Scale (MADRS) item 10, depression severity was assessed with the 6-item Hamilton Depression Rating Scale and the Clinical Global Impressions-Severity of Illness scale, and protective factors were assessed with the patient-rated Reasons for Living Inventory (RFL) assessing 6 domains. Descriptive statistics, correlation, and linear regression analysis were performed.At baseline, patients (N = 336) had varying severity of suicidal thoughts: 18% had a score ? 4. The proportion of patients with a score ? 4 decreased to 7% at week 1 and 1% at week 8 of treatment. The RFL scores at baseline were lower in patients with higher baseline suicidal thoughts and increased significantly during treatment (P < .0001). A regression model revealed that only 16% of variance in baseline total RFL score is explained by the different MADRS items. Eight patients had suicidal behavior or ideation recorded as an adverse event during the study; no consistent pattern was found in the different psychometric scores either at baseline or at the visit preceding the suicidal behavior/ideation.Suicidality rapidly decreased in hospitalized patients with severe depression treated with duloxetine. The RFL scores were low at baseline but increased during treatment, suggesting that they are at least partially state rather than trait variables. Since RFL scores are lower in depressed inpatients, these scores lose the predictive value that they have in a general population sample.ClinicalTrials.gov identifier: NCT00422162.

Project description:Introduction In the early stage of schizophrenia (first 5 years), the most important clinical target besides symptom control is relapse prevention as each relapse significantly decreases the possibility of preferable long-term outcomes. Early discontinuation of antipsychotic medication due to intolerable side-effects is one of the most common causes of relapse. Objectives This poster aims to present cariprazine’s tolerability in the early stage of schizophrenia. Methods Data from 4 randomized, double-blind, placebo-controlled trials (NCT00404573, NCT01104766, NCT01104779, NCT00694707) with similar design (1 week of wash out period, 6 weeks of treatment and 2-4 weeks of follow-up) were pooled. For the post-hoc analysis, patients with early stage of schizophrenia (defined as having a disease duration of less than 5 years) were extracted from the whole safety population, and approved doses of cariprazine (1.5-6.0 mg/day) were combined. Treatment-emergent adverse events (TEAEs) and discontinuation rates were analysed versus placebo. Results Overall, 169 placebo- (PBO) and 322 cariprazine-treated (CAR) patients were identified as having schizophrenia for less than 5 years. 67.7% cariprazine- and 56.2% placebo-treated patients reported at least one TEAE; most frequently insomnia (10.9 % CAR; 12.4% PBO), akathisia (9.6% CAR; 2.4% PBO) and extrapyramidal symptoms (9.3% CAR; 1.8% PBO). Discontinuation due to adverse events was reported in only 8.4% of cariprazine- and 14.8% of placebo-treated patients. Relapse occurred in 3.1% of cariprazine- and 5.3% of placebo-treated patients. Conclusions Cariprazine was generally well-tolerated in the early stage of schizophrenia; given the limitations of this analysis, additional research is warranted. Conflict of interest Studies were funded by Gedeon Richter Plc. and Allergan Plc (prior to its acquisition by AbbVie). Dombi, Acsai, Dr. Barabássy, Dr. Sebe, Dr. Laszlovszky, Dr Vass, Dr. Szatmári and Dr. Németh are employees of Gedeon Richter Plc., Dr. Earley and Dr. Patel a

Project description:IntroductionGreater understanding is required of how smokers with smoking-related diseases respond to smoking cessation medications. This post hoc analysis of EAGLES data compared continuous abstinence rates (CARs) in smokers with/without smoking-related diseases and assessed participant demographic and baseline characteristics that may serve as predictors of continuous abstinence (CA).MethodsEAGLES was a 24-week (12-week treatment, 12-week follow-up), double-blind, active- (nicotine replacement therapy; patch) and placebo-controlled study in motivated-to-quit smokers with/without psychiatric disorders. This analysis assessed CARs at weeks 9-12 (CAR9-12) and 9-24 (CAR9-24) in participants with smoking-related diseases [asthma, chronic obstructive pulmonary disease (COPD), diabetes, and/or cardiovascular disease (n=1372)] versus controls without these comorbidities (n=6039). Participants received varenicline 1 mg twice daily, bupropion 150 mg twice daily, nicotine patches 21 mg/day with taper, or placebo for 12 weeks. Stepwise logistic modeling was also performed to analyze odds ratio (OR) for predictors of CA at weeks 9-12 (CA9-12) and 9-24 (CA9-24).ResultsSmokers with smoking-related diseases were older, had a longer smoking history, more quit attempts, and were more likely to have a psychiatric disorder and reside in the US versus smokers without comorbidities. Fagerström Test for Cigarette Dependence scores and treatment adherence were comparable between cohorts. Smokers with smoking-related diseases had lower CARs versus controls (CAR9-12: 20.8% vs 24.0%; CAR9-24: 13.0% vs 16.9%). Use of smoking cessation medication was the strongest predictor of CA after control for demographics, smoking characteristics, and psychiatric disorder. By treatment, OR and CI were: varenicline CA9-12 (OR=3.82; 95% CI: 3.21-4.54) and CA9-24 (OR=2.92; 95% CI: 2.40-3.54); bupropion CA9-12 (OR=2.17; 95% CI: 1.81-2.60) and CA9-24 (OR=1.99; 95% CI: 1.63-2.44); nicotine patches CA9-12 (OR=2.23; 95% CI: 1.87-2.67) and CA9-24 (OR=1.86; 95% CI: 1.52-2.28).ConclusionsSmokers with smoking-related diseases had lower quit rates than controls. Of the active treatments compared, varenicline was most effective in smokers with asthma, COPD, diabetes, or cardiovascular disease.Trial registrationNCT01456936 (https://clinicaltrials.gov/ct2/show/NCT01456936).

Dataset Information

Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post-hoc analyses of a randomized, double-blind, phase III study.

Publications

Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post-hoc analyses of a randomized, double-blind, phase III study.

Similar Datasets

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